Implementing a Uniform Outcome Measurement Approach for Early Interventions of Autism Spectrum Disorders.

OBJECTIVE: Naturalistic developmental behavioral interventions for children with autism spectrum disorder show evidence for effectiveness for specific social communication targets such as joint attention or engagement. However, combining evidence from different studies and comparing intervention effects across those studies have not been feasible due to lack of a standardized outcome measure of broader social communication skills that can be applied uniformly across trials. This investigation examined the usefulness of the Brief Observation of Social Communication Change (BOSCC) as a common outcome measure of general social communication skills based on secondary analyses of data obtained from previously conducted randomized controlled trials of 3 intervention models, Early Social Intervention (ESI), Early Start Denver Model (ESDM) and Joint Attention Symbolic Play Engagement and Regulation (JASPER). METHOD: The subset of datasets from the 3 randomized controlled trials was created to examine differences in the BOSCC scores between intervention and control groups over the course of the interventions. RESULTS: Based on 582 videos from 207 caregiver-child dyads, the BOSCC noted significant differences between intervention vs control groups in broad social communication skills within 2 of the 3 intervention models, which were longer in duration and focused on a broad range of developmental skills. CONCLUSION: The BOSCC offers the potential to take a uniform measurement approach across different intervention models to capture the effect of intervention on general social communication skills but may not pick up the effects of some brief interventions targeting proximal outcomes. CLINICAL TRIAL REGISTRATION INFORMATION: Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders; https://www. CLINICALTRIALS: gov/; NCT00760812. Intensive Intervention for Toddlers With Autism (EARLY STEPS); https://www. CLINICALTRIALS: gov/; NCT00698997. Social and Communication Outcomes for Young Children With Autism; https://www. CLINICALTRIALS: gov/; NCT00953095.

Corrigendum: Understanding profound autism: implications for stigma and supports.

[This corrects the article DOI: 10.3389/fpsyt.2024.1287096.].

Does Gestural Communication Influence Later Spoken Language Ability in Minimally Verbal Autistic Children?

PURPOSE: The current study examined the predictive role of gestures and gesture-speech combinations on later spoken language outcomes in minimally verbal (MV) autistic children enrolled in a blended naturalistic developmental/behavioral intervention (Joint Attention, Symbolic Play, Engagement, and Regulation [JASPER] + Enhanced Milieu Teaching [EMT]). METHOD: Participants were 50 MV autistic children (40 boys), ages 54-105 months (M = 75.54, SD = 16.45). MV was defined as producing fewer than 20 spontaneous, unique, and socially communicative words. Autism symptom severity (Autism Diagnostic Observation Schedule-Second Edition) and nonverbal cognitive skills (Leiter-R Brief IQ) were assessed at entry. A natural language sample (NLS), a 20-min examiner-child interaction with specified toys, was collected at entry (Week 1) and exit (Week 18) from JASPER + EMT intervention. The NLS was coded for gestures (deictic, conventional, and representational) and gesture-speech combinations (reinforcing, disambiguating, supplementary, other) at entry and spoken language outcomes: speech quantity (rate of speech utterances) and speech quality (number of different words [NDW] and mean length of utterance in words [MLUw]) at exit using European Distributed Corpora Project Linguistic Annotator and Systematic Analysis of Language Transcripts. RESULTS: Controlling for nonverbal IQ and autism symptom severity at entry, rate of gesture-speech combinations (but not gestures alone) at entry was a significant predictor of rate of speech utterances and MLUw at exit. The rate of supplementary gesture-speech combinations, in particular, significantly predicted rate of speech utterances and NDW at exit. CONCLUSION: These findings highlight the critical importance of gestural communication, particularly gesture-speech (supplementary) combinations in supporting spoken language development in MV autistic children.

Examining variability in Naturalistic Developmental Behavioral Intervention strategy use in caregivers of children with autism spectrum disorders.

BACKGROUND: Naturalistic Developmental Behavioral Interventions (NDBIs) for young children with autism spectrum disorder commonly involve caregiver-mediated approaches. However, to date, there is limited research on how caregivers' skills change, and, in turn, impact child outcomes. METHODS: We evaluated the NDBI strategy use of 191 caregivers prior to participation in NDBIs (or control groups) across multiple randomized controlled trials, using the Measure of NDBI Strategy Implementation, Caregiver Change (MONSI-CC). Clustering analyses were used to examine caregiver variability in NDBI strategy use at intervention entry. Generalized Linear Mixed Models were used to examine changes in caregiver strategy use over the course of intervention and its impact on changes in children's social communication. RESULTS: Using clustering analysis, we found that caregivers' baseline skills fit four profiles: limited, emerging, variable, and consistent/high, with few demographic factors distinguishing these groups. Caregivers starting with limited or emerging skills improved in their strategy use with intervention. Caregivers starting with more skills (consistent/high or variable) maintained higher skills over intervention. Children of caregivers in these groups who received target NDBIs improved in their social communication skills. CONCLUSIONS: Results suggested that caregiver skills improve through participation in NDBIs and may directly contribute to their children's outcomes, although more research on mediating factors is needed. Individualized approaches for caregivers and their children starting with differing skill profiles at intervention entry may be warranted.

Profiles of minimally verbal autistic children: Illuminating the neglected end of the spectrum.

Heterogeneity among individuals on the autism spectrum is widely acknowledged as a barrier to develop effective interventions. Overcoming this challenge requires characterization of individual differences, especially for children that are minimally verbal and often excluded from research studies. Most studies that describe autistic subgroups identify a single minimally verbal verbal group based on a single identifying measure (e.g., ADOS module one or single item indicating absence of phrase speech). Determining personalized courses of intervention requires a more detailed understanding since a single intervention will not be effective for all who are minimally verbal. The present study identified comprehensive profiles of cognitive, language, and social communication skills within a large, diverse, group of minimally verbal children with autism. The analysis combined baseline data from two studies to yield a sample of 344 participants, who were 3 to 8 years old at the time of study onset, with 60% who identified as having a race/ethnicity other than White. Via latent profile analysis (LPA), a three-group model was identified as best fit to the data. Profile identification was dependent on a participant's combination of cognitive, expressive, and social communication characteristics, rather than a single domain. One group (n = 206) had global delays, while the other two groups (n = 95 and n = 43) had variable strengths in cognition and communication. Findings suggest that low-frequency/minimally verbal communicators with autism have heterogeneous characteristics that can be systematically organized.

Development of Restricted and Repetitive Behaviors from 2-19: Stability and Change in Repetitive Sensorimotor, Insistence on Sameness, and Verbal Behaviors in a Longitudinal Study of Autism.

This study examined trajectories of repetitive sensorimotor (RSM), insistence on sameness (IS), and verbal RRBs from ages 2-19 in a well-characterized longitudinal cohort. We also tested the factor structure of the ADI-R restricted and repetitive behavior (RRB) domain at age 19 and the inclusion of a verbal RRBs factor, in addition to previously identified RSM and IS factors, at ages 9 and 19. The ADI-R was administered to 193 participants at five timepoints from 2 to 19. Confirmatory factor analysis (CFA) was used to examine the factor structure of ADI-R RRB data. Change in RRB subtypes was examined using group-based trajectory modeling and multilevel modeling. RSM and IS behaviors generally decreased from 2 to 19, with some participants experiencing increases from ages 2-9. 46.46% of participants experienced increasing verbal RRBs from 2 to 9, followed by a plateau from 9 to 19. The remaining participants had few to no verbal RRBs throughout development. Multilevel modeling indicated ADOS CSS scores were associated with change in RSM trajectories only. Child IQ was not associated with change in any RRB trajectories. CFA indicated previously-derived RSM and IS factors fit age 19 ADI-R data well. The inclusion of a third factor, verbal RRBs, worsened goodness-of-fit statistics and was ultimately omitted. Our findings suggest the RRB factor structure of the ADI remains consistent into early adulthood and illustrate developmental continuity and change in RRBs. For autistic individuals with fluent speech, RRB presentation may be influenced by verbal ability in ways that are highly variable, but clinically meaningful.

A novel dance intervention program for children and adolescents with developmental disabilities: a pilot randomized control trial.

BACKGROUND: Organized physical activity programs have been shown to provide wide benefits to participants, though there are relatively few studies examining the impact of these programs for individuals with developmental disabilities. This pilot study was conducted to determine the feasibility and impact of an undergraduate-led dance intervention program for children and adolescents with developmental disabilities. We evaluated the impact of the dance program on motor ability and social skills. METHODS: The study design was a waitlist control clinical trial in which participants were randomized to active and control groups. Eligible participants included male and female children and adolescents between the ages of 4 and 17 years with neurodevelopmental disabilities. The Motor Assessment Battery for Children Checklist and the Social Responsiveness Scale were used to assess change in motor and social skills, respectively. After gathering baseline data, the active group completed 1 h of online dance classes per week for 10 weeks, while the control group entered a 10-week waiting period. All participants then returned for a follow-up visit. Pre- and post-intervention data were analyzed using linear mixed-effects modeling adjusting for age and class attendance with subject random intercept. RESULTS: We recruited and randomized 43 participants with neurodevelopmental disabilities (mean age = 8.63, SD = 2.98), of which 30 participated in dance classes. The attendance rate was 82.6% for the active group and 61.7% for the control group. The active group demonstrated a significant improvement in motor skills in an unpredictable environment, as indicated on the Motor Assessment Battery for Children Checklist (n = 21, p = 0.05). We also observed positive trends in social skills that did not reach significance. CONCLUSIONS: Our results indicate that it is feasible to develop and implement a fully digital dance intervention program for individuals with developmental disabilities. Further, we find that change in motor skills can be detected after just 10 h of low-intensity participation. However, a lack of significant change in social skills coupled with limitations in study implementation suggests further research is needed to determine the full impact of this dance program. TRIAL REGISTRATION: ClinicalTrials.gov Protocol Registration System: Protocol ID 20-001680-AM-00005, registered 17/2/2021 - Retrospectively Registered, https://clinicaltrials.gov/study/NCT04762290 .

Real-time coded measures in natural language samples capture change over time in minimally verbal autistic children.

Prior research supports the use of natural language sampling (NLS) to assess the rate of speech utterances (URate) and the rate of conversational turns (CTRate) in minimally verbal (MV) autistic children. Bypassing time-consuming transcription, previous work demonstrated the ability to derive URate and CTRate using real-time coding methods and provided support for their strong psychometric properties. (1) Unexplored is how URate and CTRate using real-time coding methods capture change over time and (2) whether specific child factors predict changes in URate and CTRate in 50 MV autistic children (40 males; M = 75.54, SD = 16.45 (age in months)). A NLS was collected at Time 1 (T1) and Time 2 (T2) (4.5 months between T1 and T2) and coding was conducted in ELAN Linguistic Annotator software using a real-time coding approach to derive URate and CTRate. Findings from paired samples Wilcoxon tests revealed a significant increase in child URate (not examiner URate) and child and examiner CTRate from T1 to T2. Child chronological age, Mullen expressive language age equivalent scores, and URate and CTRate at T1 were predictive of URate and CTRate at T2. Findings support using NLS-derived real-time coded measures of URate and CTRate to efficiently capture change over time in MV autistic children. Identifying child factors that predict changes in URate and CTRate can help in the tailoring of goals to children's individual needs and strengths.

Autism Severity and its Relationship to Disability.

Autism severity is currently defined and measured based exclusively on the severity levels of the two core symptom domains: social-communication and restricted or repetitive patterns of behaviors and interests. Autistic individuals, however, are often diagnosed with other medical, developmental, and psychological co-occurring conditions. These additional challenges such as intellectual disability, limited expressive and/or receptive language, and anxiety disorders, can have a tremendous impact on the day-to-day lives of autistic individuals, for both their adaptive functioning as well as their sense of wellbeing. Furthermore, the initial presentation of core symptoms and their likelihood of changing over time are influenced by the presence of such co-occurring conditions. In order to truly understand how a person's autism impacts their life, both core symptoms as well as other challenges should be considered. This approach was recently taken by The Lancet Commission on the future of care and clinical research in autism, which proposed the term "profound autism" for a subgroup of individuals presenting with high core symptom severity, co-occurring intellectual disability, and little or no language, who require extensive long-term care. Considering other individual factors such as daily living skills, specific support needs and environmental resources would also enhance the evaluation of disability in autistic individuals. As currently employed in the assessment of intellectual disability, a multidimensional approach to autism could provide a more comprehensive system for classification of impairment. At present, however, there is no formal way to designate the combined effect of these different aspects of autism on a person's life. A comprehensive outlook that acknowledges impairments, capabilities, co-occurring conditions, and environmental factors would be useful for identifying subgroups of individuals as well as for determining individual needs and strengths in clinical assessments. Lay Summary: The severity of a person's autism is currently defined based on the severity of their core autism symptoms: impaired social-communication and the presence of restricted or repetitive patterns of behaviors and interests. But autistic people often face additional challenges such as intellectual disability, epilepsy, and anxiety disorder, that considerably impact their everyday life, wellbeing, and the need for support. A more complete view of autism severity, one that includes core symptoms as well as additional challenges, could help identify meaningful sub-groups of autistic individuals and could be useful in clinical care. Appeared originally in Autism Res 2023; 16:685-696.

Measurement matters: A commentary on the state of the science on patient reported outcome measures (PROMs) in autism research.

High quality science relies upon psychometrically valid and reliable measurement, yet very few Patient Reported Outcome Measures (PROMs) have been developed or thoroughly validated for use with autistic individuals. The present commentary summarizes the current state of autism PROM science, based on discussion at the Special Interest Group (SIG) at the 2022 International Society for Autism Research (INSAR) Annual Meeting and collective expertise of the authors. First, we identify current issues in autism PROM research including content and construct operationalization, informant-structure, measure accessibility, and measure validation and generalization. We then enumerate barriers to conducting and disseminating this research, such as a lack of guidance, concerns regarding funding and time, lack of accessible training and professionals with psychometric skills, difficulties collecting large representative samples, and challenges with dissemination. Lastly, we offer future priorities and resources to improve PROMs in autism research including a need to continue to evaluate and develop PROMs for autistic people using robust methods, to prioritize diverse and representative samples, to expand the breadth of psychometric properties and techniques, and to consider developing field specific guidelines. We remain extremely optimistic about the future directions of this area of autism research. This work is well positioned to have an immense, positive impact on our scientific understanding of autism and the everyday lives of autistic people and their families.

Understanding profound autism: implications for stigma and supports.

Introduction: Societal perceptions and lack of understanding of autism spectrum disorder can be stigmatizing for autistic individuals and their families. This may be particularly the case for individuals who meet criteria for profound autism. Despite the considerable service needs of this marginalized group, there is little data on the prevalence of profound autism, nor on the experiences of those with profound autism and their families. Methods: The current study leveraged a mixed-methods approach to address these gaps. First, the prevalence of profound autism was examined in six samples-three from the United States and three from Western Europe. Second, inductive thematic analysis was used to code interviews from 20 caregivers of profoundly autistic adults. Results: The prevalence of profound autism varied widely across the six samples-from 11% to 48%. There were also notable differences between samples in prevalence by gender, race, and ethnicity. Two overarching themes were identified via inductive thematic analysis: Community Perceptions of Autism and Family Support Needs and Advocacy Challenges. Though caregivers were not directly asked about stigmatization during interviews, 85% of caregivers reported at least one instance of perceived stigma. Discussion: Future research should continue to examine the unique needs and stigmatization experiences of profoundly autistic individuals and their families across the life course.

Safe inhalation pipe provision (SIPP): protocol for a mixed-method evaluation of an intervention to improve health outcomes and service engagement among people who use crack cocaine in England.

BACKGROUND: Over 180,000 people use crack cocaine in England, yet provision of smoking equipment to support safer crack use is prohibited under UK law. Pipes used for crack cocaine smoking are often homemade and/or in short supply, leading to pipe sharing and injuries from use of unsafe materials. This increases risk of viral infection and respiratory harm among a marginalised underserved population. International evaluations suggest crack pipe supply leads to sustained reductions in pipe sharing and use of homemade equipment; increased health risk awareness; improved service access; reduction in injecting and crack-related health problems. In this paper, we introduce the protocol for the NIHR-funded SIPP (Safe inhalation pipe provision) project and discuss implications for impact. METHODS: The SIPP study will develop, implement and evaluate a crack smoking equipment and training intervention to be distributed through peer networks and specialist drug services in England. Study components comprise: (1) peer-network capacity building and co-production; (2) a pre- and post-intervention survey at intervention and non-equivalent control sites; (3) a mixed-method process evaluation; and (4) an economic evaluation. Participant eligibility criteria are use of crack within the past 28 days, with a survey sample of ~ 740 for each impact evaluation survey point and ~ 40 for qualitative process evaluation interviews. Our primary outcome measure is pipe sharing within the past 28 days, with secondary outcomes pertaining to use of homemade pipes, service engagement, injecting practice and acute health harms. ANTICIPATED IMPACT: SIPP aims to reduce crack use risk practices and associated health harms; including through increasing crack harm reduction awareness among service providers and peers. Implementation has only been possible with local police approvals. Our goal is to generate an evidence base to inform review of the legislation prohibiting crack pipe supply in the UK. This holds potential to transform harm reduction service provision and engagement nationally. CONCLUSION: People who smoke crack cocaine in England currently have little reason to engage with harm reduction and drug services. Little is known about this growing population. This study will provide insight into population characteristics, unmet need and the case for legislative reform. TRIAL REGISTRATION: ISRCTN12541454  https://doi.org/10.1186/ISRCTN12541454.

Adaptive thresholding increases sensitivity to detect changes in the rate of skin conductance responses to psychologically arousing stimuli in both laboratory and ambulatory settings.

Psychophysiologists recording electrodermal activity (EDA) often derive measures of slow, tonic activity-skin conductance level (SCL)-and faster, more punctate changes-skin conductance responses (SCRs). A SCR is conventionally considered to have occurred when the local amplitude of the EDA signal exceeds a researcher-determined threshold (e.g., 0.05 µS), typically fixed across study participants and conditions. However, fixed SCR thresholds can preferentially exclude data from individuals with low SCL because their SCRs are smaller on average, thereby reducing statistical power for group-level analyses. Thus, we developed a fixed plus adaptive (FA) thresholding method that adjusts identification of SCRs based on an individual's SC at the onset of the SCR to increase statistical power and include data from more participants. We assess the utility of applying FA thresholding across two independent samples and explore age and race-related associations with EDA outcomes. Study 1 uses wired EDA measurements from 254 healthy adults responding to evocative images and sounds in a laboratory setting. Study 2 uses wireless EDA measurements from 20 children with autism in a clinical environment while they completed behavioral tasks. Compared to a 0.01, 0.03, and 0.05 µS fixed threshold, FA thresholding at 1.9% modestly increases statistical power to detect a difference in SCR rate between tasks with higher vs. lower subjective arousal and reduces exclusion of participants by up to 5% across both samples. This novel method expands the EDA analytical toolbox and may be useful in populations with highly variable basal SCL or when comparing groups with different basal SCL. Future research should test for reproducibility and generalizability in other tasks, samples, and contexts. IMPACT STATEMENTS: This article is important because it introduces a novel method to enhance sensitivity and statistical power in analyses of skin conductance responses from electrodermal data.

A longitudinal study of loneliness in autism and other neurodevelopmental disabilities: Coping with loneliness from childhood through adulthood.

LAY ABSTRACT: We know that many autistic people feel lonely, but we don't know whether their loneliness changes over time. Our research study followed autistic people and people with other non-spectrum neurodevelopmental disabilities from childhood through young adulthood and asked them about their loneliness. While many people told us they felt lonely or very lonely, a sizable group also told us that they do not feel lonely. We found that people who reported feeling lonely earlier in life were likely to also report feeling lonely later in life. Overall, autistic people and people with other neurodevelopmental disabilities in our study became lonelier from adolescence to adulthood. People described multiple ways they cope with feeling lonely, such as distracting themselves or reaching out to connect with another person. People who used distraction tended to be lonelier than those who did not. Our findings tell us that there is a need for greater support of social connections for many autistic people as they become adults.

A Longitudinal Mixed-Methods Characterization of Family Support from Adolescence to Young Adulthood in Autism and Other Developmental Disabilities.

Although caregiving responsibilities and need for support persist and evolve across the life course in families with autistic youth or youth with other developmental disabilities (DDs), little is known about support during their child's adulthood years. Therefore, the present study used a mixed-methods approach to examine change and stability in formal and informal family support across the transition to adulthood. Caregivers of 126 individuals with autism or DDs completed a modified version of the Family Support Scale, including open-ended questions, at five time points from adolescence (age 16) into young adulthood (age 22). Caregivers reported that informal support from family members was the most frequently used, helpful, and valued source of support with relative stability across time. In contrast, the reported helpfulness, use, and value of formal support (e.g., professionals, schools) for caregivers declined over time. Qualitative content analyses revealed characteristics of highly valued support included support type (e.g., instrumental or emotional) and features of the support source (e.g., their understanding). There was a shift to valuing emotional support more than instrumental support over time, especially for caregivers of less able adults. Partnership and dependability emerged as highly valued features of the support source. These findings fit within a social convoy perspective and likely reflect the "service cliff" experienced by autistic individuals or people with DDs and their families. As social networks shrink over time and formal services are less readily available in adulthood, remaining sources of support, particularly from family members, become increasingly important.

Validation of an Enhanced Telehealth Platform for Toddlers at Increased Likelihood for a Diagnosis of Autism Spectrum Disorder (ASD).

Use of telehealth assessments for toddlers at increased likelihood of autism spectrum disorder (ASD) began prior to the global COVID-19 pandemic; however, the value of telehealth assessments as an alternative to in-person assessment (IPA) became clearer during the pandemic. The Naturalistic Observation Diagnosis Assessment (NODA™), previously demonstrated as a valid and reliable tool to evaluate asynchronous behaviors for early diagnosis, was enhanced to add synchronous collection of behaviors to assist clinicians in making a differential diagnosis of ASD. This study was conducted to validate the information gathered through NODA-Enhanced (NODA-E™) as compared to a gold standard IPA. Forty-nine toddlers aged 16.0-32.1 months of age, recruited through community pediatric offices and a tertiary ASD clinic, participated in both NODA-E and IPA assessments. There was high agreement between the two assessment protocols for overall diagnosis (46 of 49 cases; 93.6%; κ = .878), specific diagnostic criteria for social communication and social interaction (SCI; range 95.9-98%; κ = .918-.959), and for two of four criteria specified for restricted and repetitive behaviors (RRB; range 87.8-98%; κ = .755 and .959). There was lower agreement for two subcategories of RRBs (range 65.3-67.3%; κ = .306 and .347). NODA-E is a tool that can assist clinicians in making reliable and valid early ASD diagnoses using both asynchronous and synchronous information gathered via telehealth and offers an additional tool within a clinician's assessment toolbox.

Development, acceptability and feasibility of a personalised, behavioural intervention to prevent bacterial skin and soft tissue infections among people who inject drugs: a mixed-methods Person-Based Approach study.

BACKGROUND: Skin and soft tissue infections (SSTI) among people who inject drugs (PWID) are a public health concern. This study aimed to co-produce and assess the acceptability and feasibility of a behavioural intervention to prevent SSTI. METHODS: The Person-Based Approach (PBA) was followed which involves: (i) collating and analysing evidence; (ii) developing guiding principles; (iii) a behavioural analysis; (iv) logic model development; and (v) designing and refining intervention materials. Co-production activities with target group representatives and key collaborators obtained feedback on the intervention which was used to refine its design and content. The intervention, harm reduction advice cards to support conversation between service provider and PWID and resources to support safer injecting practice, was piloted with 13 PWID by four service providers in Bristol and evaluated using a mixed-methods approach. Semi-structured interviews were conducted with 11 PWID and four service providers. Questionnaires completed by all PWID recorded demographic characteristics, SSTI, drug use and treatment history. Interviews were analysed thematically and questionnaires were analysed descriptively. RESULTS: Published literature highlighted structural barriers to safer injecting practices, such as access to hygienic injecting environments and injecting practices associated with SSTI included: limited handwashing/injection-site swabbing and use of too much acidifier to dissolve drugs. Co-production activities and the literature indicated vein care and minimisation of pain as PWID priorities. The importance of service provider-client relationships and non-stigmatising delivery was highlighted through the co-production work. Providing practical resources was identified as important to address environmental constraints to safer injecting practices. Most participants receiving the intervention were White British, male, had a history of SSTI and on average were 43.6 years old and had injected for 22.7 years. The intervention was well-received by PWID and service providers. Intervention content and materials given out to support harm reduction were viewed positively. The intervention appeared to support reflections on and intentions to change injecting behaviours, though barriers to safer injecting practice remained prominent. CONCLUSIONS: The PBA ensured the intervention aligned to the priorities of PWID. It was viewed as acceptable and mostly feasible to PWID and service providers and has transferability promise. Further implementation alongside broader harm reduction interventions is needed.